Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Postmenopausal Women With Advanced Breast Cancer Clinical Trial

Official title:

Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247663
• Other study ID #: CFEM345 1601
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2005
• Last updated: April 18, 2012
• Start date: December 1999

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

- To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• Patients which participated in double blind study

Exclusion Criteria:

• Patients with intolerable toxicity.

• Patients which confirmed progressive disease during double blind study.

• Patients which have received concurrent anti-cancer therapy during double blind study.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Postmenopausal Women With Advanced Breast Cancer

Intervention

Drug:
• Letrozole

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Amagasaki	Hyogo
Japan	Novartis Investigative Site	Chuo-Ku	Tokyo
Japan	Novartis Investigative Site	Cyuo-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Hamamatsu	Shizuoka
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Kumamoto
Japan	Novartis Investigative Site	Nigata
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety during treatment
Secondary	No secondary outcomes/objectives planned